MAUDE Adverse Event Report: MORTARA INSTRUMENT ELI380 LCD AM12 WLAN USB DICOM SEC AHA B; ELECTROCARDIOGRAPH

Model Number	ELI380-ACS21
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported the connection issues.There was no adverse event reported.
Additional Manufacturer Narrative
Upon inspection the technician found the cart was not communicating.The technician performed a hard reset then set date and time to resolve.The eli 380 is intended to be a high-performance, multichannel resting electrocardiograph.As a resting electrocardiograph, the eli 380 simultaneously acquires data from each lead.Once the data is acquired, it can be analyzed, reviewed, stored, printed or transmitted.It is a device primarily intended for use in hospitals but may be used in medical clinics and offices of any size.Although there was no injury reported, if the eli380 were to have issues with cart not communicating via wireless, it could lead to a serious injury or death.Therefore, baxter is reporting this event.

• Brand Name: ELI380 LCD AM12 WLAN USB DICOM SEC AHA B
• Common Device Name: ELECTROCARDIOGRAPH
• Manufacturer (Section D): MORTARA INSTRUMENT; 7865 n 86th street; milwaukee WI 53224
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 22394389
• Report Number: 2183461-2025-00007
• Device Sequence Number: 9160328
• Product Code: DPS
• UDI-Device Identifier: 00812345026603
• UDI-Public: 812345026603
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ELI380-ACS21
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown